(102 days)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift Advanced Tissue Control (ATC) System is a modification of the UroLift UL400 System (last cleared in K193269). The primary difference is the addition of a wing component on the distal tip of the UL400 which provides a larger footprint. This design feature is intended to provide better mobilization of tissue when performing the UroLift System procedure.
The UroLift System (both the UL400 and UroLift ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UroLift System consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
The provided text is a 510(k) summary for the UroLift Advanced Tissue Control (ATC) System. It describes the device, its intended use, comparison to a predicate device, and performance testing. However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it discuss ground truth establishment, expert review, or multi-reader multi-case studies.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing (deployment, compatibility, implant/shaft/wing performance), biocompatibility, sterilization, and shelf-life testing. These are typical engineering and safety tests for a physical medical device, not a software algorithm with diagnostic or prognostic capabilities.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the context of AI/ML or diagnostic performance, nor can I answer the questions about sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.
The document explicitly states:
- "The design requirements for the UroLift System were reviewed and non-clinical design verification testing was required to assure that the modifications of the proposed device did not impact the safe and effective use of the device."
- "Non-clinical testing included deployment testing, compatibility with accessories, and implant, shaft, and wing performance testing."
- "The majority of the test methods were equivalent to the testing for the 510(k) cleared UroLift UL400 System (K193269), and all acceptance criteria were met."
This indicates that the "acceptance criteria" referred to are related to the physical performance and safety of the device, not its diagnostic accuracy or human-in-the-loop performance in an AI/ML context.
§ 876.5530 Implantable transprostatic tissue retractor system.
(a)
Identification. An implantable transprostatic tissue retractor system is a prescription use device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(3) Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity, and device functionality over the requested shelf life.
(4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Mechanical strength must be conducted.
(iii) Resistance-to-degradation testing must be conducted.
(5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance environment.
(6) In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Implant migration must be conducted.
(7) Labeling must bear all information required for safe and effective use of the device, and must include:
(i) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) Information on the patient population for which the device has been demonstrated to be effective.
(iii) A detailed summary of the device technical parameters.
(iv) Information on how the device operates and the typical course of treatment.
(v) An expiration date/shelf life.
(vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.